Portable laparoscopic trainer

ABSTRACT

A portable surgical training device is provided. The trainer includes a top cover spaced apart from a base to form a simulated body cavity for locating model organs that are substantially obscured from the field of view of the user. The top cover includes a video display, fixed insertion ports and interchangeable inserts containing simulated tissue layers. The training device has open sides for demonstrating and training lateral surgical techniques including a simulated or live tissue colon attached to a support leg for simulating transanal minimally invasive surgery. A training endoscope with an adjustable focal length for use with the trainer and, in particular, with optical trocars is disclosed. The surgical trainer can be angled and is well suited for training laparoscopic surgery techniques and demonstrating surgical instruments.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/269,113 filed on Sep. 19, 2016 entitled “Portable laparoscopictrainer” which claims priority of U.S. application Ser. No. 14/270,664filed on May 6, 2014 entitled “Portable laparoscopic trainer” whichclaims priority of U.S. application Ser. No. 13/248,449 filed on Sep.29, 2011 now U.S. Pat. No. 8,764,452 issued on Jul. 1, 2014 entitled“Portable laparoscopic trainer” which claims priority to and benefit ofU.S. Provisional Patent Application Ser. No. 61/389,141 entitled“Portable pelvic trainer” filed on Oct. 1, 2010 and U.S. ProvisionalPatent Application No. 61/476,657 entitled “Portable laparoscopictrainer” filed on Apr. 18, 2011, all of which are incorporated herein byreference in their entirety.

FIELD OF THE INVENTION

This application is generally related to surgical training tools, and inparticular, to simulators for teaching and practicing various surgicaltechniques and procedures related to laparoscopic, abdominal, andtransanal minimally invasive surgery.

BACKGROUND OF THE INVENTION

Simulated wound pelvic trainers are gaining interest in the field oflaparoscopy as they provide a functional, inexpensive and practicalmeans to train surgeons and residents the basic skills and typicaltechniques used in laparoscopic surgery such as grasping, manipulating,cutting and tying knots as well as how to perform specific surgicalprocedures such as colectomies and cholecysectomies that utilize thesebasic skills. Trainers are also effective sales tools for demonstratingmedical devices.

It can be appreciated that both the basic laparoscopic skills, as wellas surgical procedures themselves, can be practiced in a non-surgicalsetting. It has been demonstrated that the use of simulation trainersgreatly enhances the skill levels of new laparoscopists, and are a greattool to train future surgeons in a non-surgical setting. There is a needfor improved, realistic and effective surgical trainers.

SUMMARY OF THE INVENTION

The present invention generally provides a modular pelvic simulationtrainer that accommodates different insert modules to facilitatetraining on a wide variety of minimally invasive surgical procedures,including, for example, the insertion of trocars, performing minimallyinvasive procedures through trocars, hand-assisted access devices, andsingle-site port devices.

According to one aspect of the invention, a surgical training device isprovided. The training device comprises a base and a top cover that isconnected to and spaced apart from the base by at least one leg todefine an internal cavity between the top cover and the base. Thetraining device has substantially open sides and further includes afirst insert connected to the top cover. The first insert has a topportion removably connected to a bottom portion to form an encasementhaving an opening in the top portion and an opening in the bottomportion. The encasement houses a removable insert material thatsimulates human tissue. The insert material is disposed between the topportion and the bottom portion of the first insert providing apenetrable tissue simulation region for accessing the internal cavity.

According to another aspect of the invention, a surgical training deviceis provided. The surgical training device comprises a base and a topcover connected to and spaced apart from the base to define an internalcavity between the top cover and the base. At least one leginterconnects and spaces apart the top cover and base. The at least oneleg has an aperture facing the internal cavity. The surgical trainingdevice further includes a tube having a proximal end and a distal end.The proximal end of the tube is interconnected with the aperture suchthat the aperture provides an access port to the lumen of the tube. Thedistal end of the tube extends into the internal cavity and is suspendedwithin the internal cavity.

According to another aspect of the invention, a sleeve or endoscope tipis provided that, when coupled to the camera, facilitates the rapidchange in focal depth of the camera, thus enabling a single, simple andcost effective camera to be used to focus both on the interior of thetrainer, for monitoring simulated laparoscopic procedures, and on thetip of an instrument, as for example, monitoring the insertion of atrocar through a simulated abdominal wall.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a top perspective view of a surgical training deviceaccording to the present invention.

FIG. 2 illustrates a top perspective view of a top cover of the traineraccording to the present invention.

FIG. 3 illustrates a side view of an insert adapted to simulate across-section of the abdominal wall according to the present invention.

FIG. 4 illustrates a partial top perspective view of an insert having acircular opening according to the present invention.

FIG. 5A illustrates a top perspective view of an insert having acircular opening according to the present invention.

FIG. 5B illustrates a top perspective view of an insert having acircular opening according to the present invention.

FIG. 6 illustrates a top perspective view of a single-port device in aninsert according to the present invention.

FIG. 7 illustrates a top perspective view of an endoscope according tothe present invention.

FIG. 8 illustrates a perspective, partially transparent view of a distalend of an endoscope according to the present invention.

FIG. 9A illustrates a perspective, partially transparent view of a lensassembly tip according to the present invention.

FIG. 9B illustrates a cross-sectional view of a lens assembly tipattached to a distal end of an endoscope according to the presentinvention.

FIG. 10A illustrates a perspective, partially transparent view of asleeve on a distal end of an endoscope according to the presentinvention.

FIG. 10B illustrates a cross-sectional view of a sleeve on a distal endof an endoscope according to the present invention.

FIG. 11 illustrates a cross-sectional view of a distal end of anendoscope with a flexible tip according to the present invention.

FIG. 12 illustrates a perspective view of another variation of thelaparoscopic trainer according to the present invention.

FIG. 13 illustrates a top view of the laparoscopic trainer of FIG. 12according to the present invention.

FIG. 14 illustrates a perspective, cross-sectional view of an insertaccording to the present invention.

FIG. 15 illustrates an exploded perspective view of an insert accordingto the present invention.

FIG. 16A illustrates an exploded side view of an insert according to thepresent invention.

FIG. 16B illustrates a top perspective view of an insert materialaccording to the present invention.

FIG. 17 illustrates a perspective view of a laparoscopic trainer with aleg with an insert and attached tube according to the present invention.

FIG. 18 illustrates a perspective view of a leg with attached tube andinsert according to the present invention.

FIG. 19 illustrates a perspective view of a leg with a insert accordingto the present invention.

FIG. 20 illustrates a perspective view of a laparoscopic trainer with anaccess device, insert and tube with artificial tumors according to thepresent invention.

FIG. 21 illustrates a perspective view of a laparoscopic trainerangulated forwardly according to the present invention.

FIG. 22 illustrates a perspective view of a laparoscopic trainerangulated backwardly according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Hand-access devices, single-port devices and retraction devices similarto embodiments disclosed herein are disclosed in U.S. Pat. Nos.7,473,221, 6,958,037, 7,650,887, U.S. Published Patent Application No.2009-0187079, and U.S. Published Patent Application No. 2010-0094227,the disclosures of which are incorporated herein by reference in theirentireties.

FIG. 1 shows one embodiment of the disclosed portablepelvic/laparoscopic trainer, comprising a torso-shaped top cover 1,which is connected to a bottom plate or base 2 through collapsiblehinges 3. A monitor 4 is attached to the top cover 1 and can be foldedagainst the top cover 1 for portability or storage in a low-profileorientation.

Also shown in FIG. 1 is one embodiment of an insert 5 that fits into anopening in the top cover 1. In this embodiment, the insert 5 hasmultiple, fixed apertures 6, which optionally function as trocar orsurgical instrument insertion sites, as well as one large opening 7,into which a hand-access device, single-site device or tissue simulationregion may be inserted. The insert 5 is formed from a material havingsufficient strength and rigidity to provide mechanical support for thehand access or single-site device during use. One preferred material isa hard plastic, which provides sufficient rigidity and strength, butwhich is light weight for easy portability of the trainer unit. Inanother variation, the apertures 6 and opening 7 are formed directly inthe top cover 1.

As shown in FIG. 2, another embodiment of the top cover 8 has an opening9 adapted to accept other embodiments of inserts, for example, a foampad to simulate the skin or several layers of skin and tissue. Inanother embodiment, the insert may contain multiple layers of foam orother suitable material, preferably color-coded to simulate the variouslayers of the abdominal wall.

A schematic of a pad or insert 5 simulating the abdominal wall is shownin FIG. 3. In this variation of the insert 5, multiple layers of foam orfoam-like material are used to simulate the appearance, texture anddensity of the various layers of the abdominal walls. For example, a toplayer 10 simulating the skin may be fashioned from a pink, beige, tan,brown or black material. One suitable material is the beige/tan, orangeor pink foam sheets by CREATIVE HANDS®, available in 2 mm thicknesssheets.

A second layer 11 may be added to the pad, simulating a subcutaneous fatlayer. One suitable material for this layer is seat cushion foam,available at most fabric stores in one-inch thick sheets. Alternatively,two to three sheets of closed cell packing material, available as paddedwrap from most hardware stores in approximately ⅛-inch thick sheets, maybe used.

A third layer 12 of one or more sheets is added to the pad to simulatethe muscle layers of the abdominal wall. One suitable material for thislayer is Red Foamie CREATIVE HANDS® Foam, preferably two to three sheetsstacked together. Preferably, two to three layers of simulated muscle asused in the pad.

A fourth layer or layers 13 of simulated fascia may be disposed betweenthe simulated muscle layers 12. One suitable material for the simulatedfascia is thin dish pack, available at most office supply or hardwarestores.

A fifth layer 14, simulating the pre-peritoneal fat layer, may also befashioned from two to three sheets of closed cell packing material.

As described herein, an insert simulating an abdominal wall can be usedto train operators on the proper technique for inserting a trocar. Inparticular, the use of optical trocars allows the visualization of theinsertion process into the skin, and protrusion into the abdominalcavity. Using a camera or endoscope adapted to focus on the tip of thetrocar, users can track the progress of the trocar insertion through thevarious layers of the simulated abdominal wall on the display monitor ofthe trainer.

FIG. 4 shows a close-up view of another variation of an insert 5 havinga large circular opening 16 adapted to accept a hand-access device orsingle-site device. Since the use of a hand-access device in anon-clinical training environment requires the insert to be stable andrigid, the edge 17 will feel un-natural to the trainee when it iscontacted by the trainee during use. Similarly, the use of a single-sitedevice on simulated tissue will feel rigid and un-natural to the traineewhen the edge 17 is touched with laparoscopic tools during use in atraining environment. To provide a more natural feel, FIG. 5Aillustrates a retractor 18 placed inside the opening 16 of an insert 5or directly into an opening 7 of the top cover 1 of the trainer. Theretractor 18 includes an annular ring 19 that provides a softer, morenatural-feeling edge 20. Similarly, FIG. 5B illustrates a retractor 21that has a smaller diameter annular ring 22 to provide a softer, morenatural-feeling edge 23. In one variation, the annular ring 19, 22 isformed from silicone, but as the skilled practitioner will note, othermaterials that simulate the tactile feel and density of a wound incisionsite, particularly one protected by a wound retractor, can be used. Theretractor 18 with a larger diameter opening is particularly useful witha hand-access device, while the retractor 21 with a smaller diameteropening is particularly useful with a single-site device. A single-sitedevice is an access portal inserted into a single incision in thepatient typically made at the navel through which an endoscope and othersurgical hand instruments are inserted to perform advanced, minimallyinvasive laparo-endoscopic surgery.

FIG. 6 shows a single-site device 24 that is secured to the insertretractor 21 of FIG. 5B. An endoscope and working tools such asgraspers, scissors, etc. are inserted through the trocar ports 25, 26,27 to enter the trainer cavity. As the user manipulates the endoscopecamera and hand tools within the confines of the trocar ports 25, 26,27, the tools and/or camera may contact the edge 23 of the retractor 21which will now feel more natural, while the underlying surface of theinsert 5 or large opening 7 will still provide sufficient rigidity toprovide mechanical support for the single-site device 24 or hand-accessdevice during use.

FIG. 7 shows a schematic drawing of a laparoscope that is part of thelaparoscopic trainer disclosed in this invention. The laparoscopecomprises a camera 28 that is mounted at the distal end of a shaft 29,which connects to a handle 30. The camera 28 is powered, and the videosignal is fed through cable 31, which terminates in a plug 32 forconnection to a computer, video display, and power source. Plug 32connects to the directly to the trainer, where it connects to electricalpower and a monitor display. The electrical power source may be externalor internal to the trainer.

As shown in FIG. 8, the distal end of the camera shaft 33 houses a CMOSor CCD-based camera 34 which incorporates a lens system to provide for afocal depth of 4-inches to infinity, although the typical working focaldepth for the trainer is approximately four to six inches. The scope tip35 also incorporates light emitting diodes (LEDs) to enhanceillumination during general use. The scope is insertable into opticaltrocars having a transparent distal end for viewing the insertion of theoptical trocar through simulated tissue of the trainer where all ambientlight is blocked. In such a case, the illumination at the tip of thescope provided by the LEDs is helpful for viewing the procedure. Inaddition to illumination, the visualization of the optical trocarinsertion procedure also requires that the focal depth of the camera isreduced to about 5 to 10 mm, preferably about 7 mm, which is the typicaldistance between the tip of the scope and the tip of the obturator whenthe scope is inserted inside the optical trocar. In one variation of thepresent invention, the change in the focal length of the camera isachieved by adding a lens assembly tip or cap 36, 36′ to the end of thescope. The lens assembly tip 36, 36′ of the camera 34, 34′ is shown inFIGS. 9A and 9B, respectively, where a lens 38, 38′ is mounted to a tube37, 37′ that connects via connecting pins 39, 39′ to the scope shaft 40,40′. In one variation, the lens assembly tip 36, 36′ is attached to thescope shaft 40 by screw threads or a snap-fit engagement so that thelens assembly does not detach when the scope is retracted from theobturator after insertion into the simulated skin. It should be notedthat while FIGS. 9A and 9B show the lens assembly tip 36, 36′ asexternal to the scope shaft 40 the lens assembly tip 36, 36′ is disposedentirely within the scope shaft 40 in another variation. In yet anothervariation, the change in the focal length of the camera is achieved bymounting a lens 42, 42′ to the end of a thin sleeve 41, 41′ that ispulled over the scope shaft 43, 43′, as shown in FIGS. 10A and 10B,respectively.

In either of the two embodiments described above, it will be appreciatedby one of skill in the art that the trainer scope/camera can quickly andeasily be converted from use with a single-site or hand-access device,wherein the operative focal depth is approximately 4 to 6 inches, to usewith an optical trocar to monitor insertion through a simulatedabdominal wall, wherein the operative focal depth is approximately of 5to 10 mm, by either snapping or threading a tip onto the end of thescope or by sliding a sleeve over the shaft of the scope.

FIG. 11 shows yet another embodiment of the present invention, whereinthe distal end of the shaft housing the camera 34 and/or LEDs can beconnected via a flexible connector 44 to the remainder of the scopeshaft 40 for variable angulation of the distal end of the scope. Inanother variation, the distal end of the scope is fixed at an angle ofapproximately 30 or 45 degrees with respect to the proximal end of theshaft 40 and in another variation, the distal end of the shaft is notangled with respect to the proximal end of the shaft 40 but the opticsinternal to the shaft 40 are configured to provide a fixed or variableangled field of view.

Referring now to FIGS. 12 and 13, there is shown a surgical trainer 50according to the present invention. The endoscopic trainer 50 includes atop cover 52 connected to a base 54 by a plurality of legs 56. Thelaparoscopic trainer 50 is configured to mimic the torso of a patientsuch as the abdominal region. The top cover 52 is representative of theanterior surface of the patient and the space between the top cover 52and the base 54 is representative of an interior of the patient or bodycavity where organs reside. The trainer 50 is a useful tool forteaching, practicing and demonstrating various surgical procedures andtheir related instruments in simulation of a patient. Surgicalinstruments are inserted into the cavity through pre-establishedapertures in the top cover 52. Various tools and techniques may be usedto penetrate the top cover 52 to perform mock procedures on model organsplaced between the top cover 52 and the base 54. The base 54 includes atray (not shown) for holding simulated or live tissue. The tray isplaced in a tray-receiving portion 60 of the base 54. The tray-receivingportion 60 of the base 54 includes frame-like elements for holding thetray in place. To help retain simulated or live organs on the base, aclip attached to a retractable wire is provided at locations 61.

A video display monitor 62 that is hinged to the top cover 52 is shownin a closed orientation in FIGS. 12 and 13 and in an open orientation inFIGS. 1, 21 and 22. The video monitor 62 is connectable to a variety ofvisual systems for delivering an image to the monitor. For example, anendoscope inserted through one of the pre-established apertures or awebcam located in the cavity and used to observe the simulated procedurecan be connected to the video monitor 62 and/or a mobile computingdevice to provide an image to the user. Also, audio recording ordelivery means may also be provided and integrated with the trainer 50to provide audio and visual capabilities. Means for connecting aportable memory storage device such as a flash drive, smart phone,digital audio or video player, or other digital mobile device is alsoprovided, to record training procedures and/or play back pre-recordedvideos on the monitor for demonstration purposes. Of course, connectionmeans for providing an audio visual output to a larger screen other thanthe monitor is provided. In another variation, the top cover 52 does notinclude a video display but includes means for supporting a laptopcomputer, a mobile digital device or tablet such as an IPAD® andconnecting it by wire or wirelessly to the trainer.

When assembled, the top cover 52 is positioned directly above the base54 with the legs 56 located substantially around the periphery andinterconnected between the top cover 52 and base 54. The top cover 52and base 54 are substantially the same shape and size and havesubstantially the same peripheral outline. Although the trainer 50 hasno sidewalls, the legs 56 partially obscure the internal cavity fromview from an otherwise open-sided trainer 50. In the variation shown inFIG. 12, the legs include openings to allow ambient light to illuminatethe internal cavity as much as possible and also to advantageouslyprovide as much weight reduction as possible for convenient portability.The top cover 52 is removable from the legs 56 which in turn areremovable or collapsible via hinges or the like with respect to the base54. Therefore, the unassembled trainer 50 has a reduced height thatmakes for easier portability.

Still referring to FIGS. 12 and 13, the top cover 52 includes a firstinsert 64 removable and replaceable with respect to the top cover 52, inparticular, insertable into and removable from an opening formed in thetop cover 52. The first insert 64 includes a plurality of apertures 66to serve as fixed insertion ports for a variety of instruments. Theapertures 66 may include various seals. The first insert 64 alsoincludes a tissue simulation region 68 for simulating the skin orseveral layers of tissue.

In one embodiment, the tissue simulation region 68 is configured as asecond insert 70 provided within the first insert 64. The second insert70 is removable and replaceable via snap-fit, friction fit or threadedengagement or other means with respect to the top cover 52 or withrespect to the first insert 64 if provided. In the embodiment shown inFIGS. 12 and 13, the second insert 70 is removable and replaceable withrespect to the first insert 64. Of course, one or more second inserts 70or tissue simulation regions 68 may be provided in the first insert 64or directly in any location of the top cover 52 with or without the useof a first insert 64. The tissue simulation regions 68 are connected tothe top cover 52 and are removable and replaceable.

Referring now to FIGS. 14-16, there is shown one variation of the secondinsert 70. The second insert 70 is generally cylindrical with a circularcross-section although any shape may be used such that the second insert70 is insertable and removable with respect to a complementarily shapedopening in the top cover 52 or in the first insert 64. The second insert70 includes a top ring or top portion 72 threadingly connected to abottom ring or bottom portion 74 forming an encasement with insertmaterial 76 located there between providing a tissue simulation region68 for the user. The top ring 72 includes a top surface 78 and asidewall 80 with a threaded outer surface. The top surface 78 extendsinwardly to create an upper ledge encompassing an opening. The topsurface 78 also extends outwardly to create a lip for resting on thefirst insert 64 or top cover 52. In one variation, the upper ledgeincludes at least one downwardly extending projection or spur (notshown) configured to dig into and grip the insert material 76 to helpretain it in position. The bottom ring 74 includes a bottom surface 82and sidewall 84 with a threaded inner surface. The bottom surface 82extends inwardly to create a lower ledge encompassing an opening toretain, along with the upper ledge, the layers of simulated tissueinside the insert 70. In one variation, the lower ledge includes atleast one upwardly extending projection or spur (not shown) configuredto dig into and grip the insert material 76 and help retain it inposition. In another variation, the insert 70 includes a support ring 86sized to fit inside the ring structure. The top ring 72 and bottom ring74 are connected via threads to capture the insert material 76 andsupport ring 86, if used, inside the ring structure between the upperand lower ledges. The top ring 72 and bottom ring 74 are alsoconnectable via other means such as by snap-fit and interference fitengagement. A portion of the insert material 76 interior of the upperledge remains exposed and accessible from the top and a portion of theinsert material 76 interior of the lower ledge is exposed and accessibleand visible from the bottom. The exposed portions are suitable forpracticing penetration of tissue with various instruments such astrocars, scalpels and the like. The second insert 70 is insertable intoa complementary shaped aperture in the top cover 52 or, in analternative variation, the first insert 64 and is securely but removablyconnected thereto. The insert material 70 simulates a penetrable tissuelayer through which instruments may be passed to access the body cavityto practice various procedures on simulated organs and the like locatedin the simulated body cavity and substantially hidden from view by thetop cover 52.

With particular attention to FIGS. 16A and 16B, the insert material 76is selected to simulate the look and feel of that portion of the humanbody to be penetrated. A different number of layers having differentconsistencies, compositions and colors are selected to best simulate thedifferent areas of the human body for which the insert is configured.Alternatively, the insert material 76 may be selected to simulate anaccess device that provides a penetrable gel or silicone layer throughwhich instruments may be passed. As shown in FIGS. 14-16, multiplelayers can be employed to simulate different areas of the human body tobe penetrated. For example, in FIG. 16A, multiple layers are shown tosimulate abdominal tissue. The first layer 88 is a skin layer, a secondlayer 90 simulates a subcutaneous fat layer, a third layer 92 representsa fascia layer, a fourth layer 94 represents a muscle layer, a fifthlayer 96 represents another fascia layer, a sixth layer 98 represents apre-peritoneal fat layer, and a seventh layer 100 simulates theperitoneum. The different types of layers have different thicknesses,compositions and colors to closely approximate real abdominal tissuelayers. An eighth layer 102 made of ethyl vinyl acetate (EVA) is alsoincluded. In this variation, all of the layers are EVA foam layersexcept for the fat layers which are made of yellow cellulose sponge andthe peritoneum layer which is made of clear polyolefin. When backed bythe eighth layer 102 of EVA, the polyolefin layer visually and tactilelyresembles a real peritoneum while being penetrated by an opticalobturator and observed via an endoscope disposed inside the opticalobturator whereas the cellulose sponge advantageously provides anirregular look typical of real human fat.

With reference to FIG. 16B, in another variation that simulatesabdominal tissue, the insert material 76 comprises a plurality of layersstacked upon each other in which the first layer 88 from the topsimulates a skin layer. The first layer 88 is made of tan colored EVAfoam. The second layer 90 simulates a subcutaneous fat layer and is madeof yellow cellulose sponge. The third layer 92 represents a fascia layerand is made of white EVA foam. The fourth layer 94 represents a musclelayer and is made of red EVA foam. The third layer 92 is adjacent to thefourth layer 94. A fifth layer 96 is a support layer made of translucentfoam that is pink in color and made from closed cell polyethylene foam.A sixth layer 98 is another muscle layer and is made of red EVA foam.The translucent pink closed cell polyethylene foam layer is adjacent tothe red EVA foam layer. The seventh layer 100 simulates another fascialayer and is made of white EVA foam. The eighth layer 102 represents aperitoneum layer and is made of translucent white closed cellpolyethylene foam. The ninth layer 103 is another support layer tovisually and tactilely resemble the peritoneum. The ninth layer 103 ismade of white EVA foam. The white EVA foam layer is adjacent to thetranslucent white closed cell polyethylene foam layer. The closed cellpolyethylene foam employed in the insert material 76 as a support layer96 between two muscle layers 94, 98 advantageously provides a realistichaptic response when penetrated by the surgeon using an obturator. Theclosed cell polyethylene foam layer provides a tactile pop whenpenetrated. Because endoscopic surgery relies on the visualization ofthe operative field via an endoscope where the image may be obscured bytissue, blood, fluids and moisture condensation, the surgeon traineelearns to develop a keen haptic sense when certain bodily tissues arehandled or penetrated with surgical instruments. The insert material ofthe present invention provides an effective way for teaching the surgeonto develop that haptic sense. Similarly, the eighth layer 102 thatsimulates the peritoneum is also made of closed cell polyethylene foamthat advantageously provides a realistic haptic feedback to the surgeontrainee that the peritoneum has been penetrated. Because the eighthlayer 102 is closer to the bottom of the insert the haptic response ismore pronounced compared to the haptic response generated by thepolyethylene layer, such as the fifth layer 96, that is cushioned orsurrounded by more layers on either side which muffle the hapticresponse.

The support ring 86 is an optional means to provide support for theinsert material 76 and serves to prevent the insert material 76 frombeing pushed through the opening in bottom ring 74 when an instrument isbeing inserted. The support ring 86 also provides a degree ofcompression to the insert material 76 when inserted into the ringstructure to simulate the resiliency of real tissue. A support ring 86is interchangeable and may be substituted with another support ring 86of different thickness as required to simulate different areas of thebody to be penetrated. For example, a thinner insert material 76representing a thinner tissue layer may necessitate a thicker supportring 86 inserted into the ring structure. Hence, the overall thicknessof the second insert is advantageously kept constant whereas thethicknesses of the insert material and support ring may vary as requiredto simulate the desired tissue characteristics. The support ring 86provides a thickness adjustment layer for insert material 76 ofdifferent thicknesses. The multiple layers of the insert material 76 areconnected with glue or other means such as by one or more plastic pricetag holders 105 as shown in FIG. 16B that are typically I-shaped andpassed through all of the layers to keep them together. In anothervariation, the multiple layers of insert material 76 are captured in aheat shrink plastic sleeve having an open top and bottom.

A user may select an appropriate insert material 76 and associatedsupport ring 86 for the part of the body to be penetrated. The supportring 86 is first inserted into the bottom ring 74, then, the insertmaterial 76 is placed on top of the support ring 86 eitherlayer-by-layer or as a single biscuit having all the layers connectedtogether with, for example, one or more price tag holders 105 as shownin FIG. 16B. The top ring 72 is then connected to the bottom ring tocapture the insert material 76 and support ring 86 there between. Thesecond insert 70 can then be disposed in a corresponding aperture in thetop cover 52 of the trainer 50 and connected thereto by threaded,snap-fit, compression-fit or other means known to one having ordinaryskill in the art. A user may then demonstrate, practice or teach variousprocedures using various instruments penetrating the insert material 76and observing the penetration and procedures via the camera/scope withvideo images displayed on the video monitor 62. After multiplepenetrations of the insert material 76 with the same or differentinstruments, the user may then remove the second insert 70 from the topcover 52, unscrew the top ring 72 from the bottom ring 74, remove anddiscard the insert material 76 and insert a new insert material 76 intothe ring structure for another demonstration or more practice. The usermay carry multiple insert layers 76 of different combinations ofconstituting layers and reconstruct the second insert 70 as desiredwithout necessitating reconstruction of a larger insert or having tosend the insert 70 to the manufacturer to be reconstructed. Of course,in another variation, the entire second insert 70 may be avoided and thefirst insert 64 fashioned in the same manner as the second insert 70just described to provide for a larger simulated tissue region.

Referring back to FIG. 12, there is shown a top cover supported abovethe base by five legs. In one variation, a sixth leg is provided asshown in FIGS. 17-20. The trainer 50 may be assembled with an optionalsixth support structure or leg 106 which is configured for simulatingtransanal endoscopic micro-surgery (TEMS) also known as transanalminimally invasive surgery (TAMIS).

The TEMS or TAMIS leg 106 includes a flat plate 108 having an innersurface for facing toward the interior of the trainer and an outersurface for facing outwardly towards the user. The plate 108 has anaperture 110 passing through the plate 108 from the inner surface to theouter surface. As shown in FIGS. 18 and 19, the plate 108 also includesmeans such as tabs 112 or a U-shaped channel 114 for inserting toconnect the TEMS or TAMIS leg 106 to the top cover 52 and to the base 54to help support and space apart the top cover 52. The TEMS or TAMIS leg106 is provided with a sphincter insert 116 to simulate an anus. Thesphincter insert 116 is typically made of silicone to provide arealistic tissue-like interface. The sphincter insert 116 is insertableinto the aperture 110 of the leg 106 and includes an aperture 118coaxial with the plate aperture 110. In another variation, the insert116 is glued or over molded to the leg 106 such that the insert 116substantially faces outwardly toward the user. On the inner surface ofthe leg 106, a tube 120 is connected such that the lumen of the tube 120is in communication with the aperture 110 of the leg 106 and if asphincter insert 116 is utilized, the lumen of the tube 120 is connectedsuch that it is in communication with the aperture 118 in the sphincterinsert 116. In another variation, a connector (not shown) is attached tothe inner surface of the leg 106. The connector is acylindrically-shaped extension having a radially-extending distalflange. The connector is configured for attaching the tube 120 to theconnector by pulling the tube 120 over the distal flange and over theconnector which has a connector diameter larger than a relaxed tubediameter to keep the tube 120 secured to the leg 106. The tube 120 maybe suspended from the under surface of the top cover 52 with tetheredclips 122 connected to the under surface of the top cover 52 as shown inFIG. 20. The tube 120 may be made of inanimate tissue such as a calfcolon. Alternatively, the tube 120 is designed to simulate a bowel,intestine or colon and is made of silicone. Artificial tumors 124illustrated in FIG. 20 are also disposed on the tube 120 so that theuser may practice locating and removing them. In one variation, theartificial tumors 125 are darker in color than tube and located insidethe tube lumen. At the outer surface of the plate 108, an access device126 may be provided and inserted into the sphincter insert 116 and intothe aperture 110 as shown in FIG. 20. The access device 126 seals theproximal opening of the tube 120 at the leg 106 and provides aninsufflation port 128 for delivering insufflation fluid into the tube120 to expand the tube 120 and create a working space inside the tube120 to simulate an actual TEMS/TAMIS procedure. If insufflation isemployed, a tube 120 with a sealed distal end is provided to contain theinsufflation gasses. Simulated insufflation in which a tube 120 isconfigured to simulate an already inflated colon may be employed withoutthe use of pressurization or gas. Such a tube 120 is configured to belarger and distended as if it were insufflated with gas. The leg 106advantageously provides a lateral approach to the body cavity of thetrainer 50 for yet another range of procedures that require a lateral oranal approach. The leg 106 and accompanying tube attachment isparticularly useful for users to practice closing incisions in the tube120 with sutures performed through the top cover 52 or laterally throughthe leg 106. A silicone tube does not tear as easily as other materialswhen closing an incision therein with sutures and provides an idealpracticing environment and medium. Lighting such as LEDs (not shown)attached to the under surface of the top cover 52 is provided toilluminate the body cavity. The trainer 50 is suitable for simulationsthat are not limited to practicing or demonstrating laparoscopicprocedures including gynecological and urological procedures but mayalso be employed for other surgical procedures requiring a lateralapproach including orthopedic applications.

Turning now to FIGS. 21 and 22, another variation of the trainer 50having a top cover 52 that angulates with respect to the base 54 isshown. This variation includes two legs 130, 132 that connect andseparate the top cover 52 and the base 54. The legs 130, 132 areconfigured to permit the angle of the top cover 52 with respect to thebase 54 to be adjusted. The angulation of the trainer advantageouslysimulates a patient in a Trendelenburg or reverse Trendelenburgposition. In the Trendelenbury position the body is tilted such that itis laid flat on the back with the feet higher than the head or viceversa. The Trendelenburg position allows better access to the pelvicorgans as gravity pulls the intestines away from the pelvis to therebyprevent encroachment of the intestines upon the pelvic operating fieldto provide more working space inside the abdominal cavity in which thesurgeon can more easily manipulate organs. The degree of tilt of thetrainer is approximately 0 to ±60 degrees. The selected angulation islocked by tightening thumbscrews provided on the legs 130, 132. A trayfor holding simulated or live tissue inside the simulated cavity isconfigured to angulate independently with respect to the base as well orconnected to the top cover 52 such that angulation of the top cover 52simultaneously angulates the tissue tray. While FIGS. 21 and 22 showonly the top cover 52 angulating with respect to the base 54, anothervariation provides for angulation of the entire trainer 50 with respectto a table top. Such trainer 50 is provided with tilting means such asone or more jack screws or other height adjustment mechanisms known to aperson skilled in the art. The jack screws, for example, are provided ineach corner of the base 54 and are adjustable for custom angulation ofthe entire trainer 50 with respect to a table top. Although FIGS. 21 and22 depict the trainer 50 angulating forwardly and backwardly, thetrainer 50 may also be configured to angulate side to side.

While certain embodiments have been particularly shown and describedwith reference to exemplary embodiments thereof, it will be understoodby those of ordinary skill in the art that various changes in form anddetails may be made therein without departing from the spirit and scopethereof as defined by the following claims.

We claim:
 1. A surgical training device, comprising: a base; a top coverconnected to and spaced apart from the base by at least one leg todefine an internal cavity between the top cover and the base withsubstantially open sides; a first insert connected to the top cover; thefirst insert includes a top portion removably connected to a bottomportion to form an encasement having an opening in the top portion andan opening in the bottom portion; the first insert further includes aremovable insert material simulating human tissue disposed between thetop portion and the bottom portion of the first insert providing apenetrable tissue simulation region for accessing the internal cavity.2. The surgical training device of claim 1 wherein the top coverincludes a first opening configured to receive a second insert; thesecond insert being removably inserted into the first opening andremovably connected to the top cover; the second insert includes asecond opening configured to receive the first insert; the first insertbeing inserted into the second opening and connected to the secondinsert.
 3. The surgical training device of claim 2 wherein the secondinsert includes at least one insertion port having a seal.
 4. Thesurgical training device of claim 1 wherein the insert material includesmultiple layers.
 5. The surgical training device of claim 4 wherein atleast one of the layers is made of cellulose sponge.
 6. The surgicaltraining device of claim 4 wherein the insert is configured such that atleast one layer of the insert material provides a haptic response whenpenetrated.
 7. The surgical training device of claim 6 wherein the atleast one layer of insert material that provides a haptic response whenpenetrated is made of closed cell polyethylene foam.
 8. The surgicaltraining device of claim 4 wherein the insert material includes atranslucent pink closed cell polyethylene foam layer adjacent to a redEVA foam layer.
 9. The surgical training device of claim 1 wherein thefirst insert includes a removable support ring disposed between the topportion and the bottom portion.
 10. The surgical training device ofclaim 1 wherein the top cover is configured to angulate with respect tothe base.
 11. The surgical training device of claim 1 wherein thesurgical training device is configured to angulate with respect to atable top on which it is placed.
 12. A surgical training device,comprising: a base; a top cover connected to and spaced apart from thebase to define an internal cavity between the top cover and the base; atleast one leg interconnecting and spacing apart the top cover and base;the at least one leg having an aperture facing the internal cavity; atube having a proximal end and a distal end; the proximal end beinginterconnected with the aperture such that the aperture provides anaccess port to the lumen of the tube; the distal end of the tubeextending into the internal cavity.
 13. The surgical training device ofclaim 12 further including an insert having an opening and connected tothe leg; the opening of the insert being in communication with the lumenof the tube and configured to provide a realistic tissue-like interface.14. The surgical training device of claim 13 wherein the insert issubstantially annular in shape and the opening of the insert iscircular.
 15. The surgical training device of claim 12 wherein the tubeincludes artificial tumors attached to the tube.
 16. The surgicaltraining device of claim 12 wherein the tube is adapted for insufflationsuch that the distal end of the tube is closed and the proximal end ofthe tube is sealed to prevent the escape of insufflation fluid.
 17. Thesurgical training device of claim 16 wherein the proximal end of thetube is sealed with a removable access device having an insufflationport for delivering insufflation fluid into the tube.
 18. The surgicaltraining device of claim 12 wherein the tube is distended to simulate aninsufflated colon.
 19. The surgical training device of claim 12 whereinthe at least one leg is located along the periphery of the both the topcover and base.
 20. The surgical training device of claim 12 wherein thetube is suspended from the top cover.